Biomet Microfixation outer packaging labeled in part:"REF: SP-2411***RUBBER BAND, LATEX FREE SMALL, HEAVY, 300/PACKAGE 4

FDA device recall Z-0012-2012 · posted 2011-10-05 · Terminated

Recall details

Recalling firm

Biomet Microfixation, Inc.

Reason for recall

On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies.

Action taken

Biomet Microfixation, Jacksonville, FL sent a Urgent Medical Device letter dated August 19, 2011, to all affected customers. They were also notified by phone, and followed-up by e-mails starting on 08/18/2011. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed If you have any of the affected products in your facility, please remove it and return it immediately to Biomet Microfixation for credit. In order to return these products, please utilize the Return Goods Authorization (RGA) number provided on the reconciliation form. Please follow the instructions on the form and fill out the attached Inventory Reconciliation sheet and FAX to (904) 741-9425. If you have any further questions, please call 1-800-874-7711 or (904) -741-4400, extension 9468, Monday through Friday, 8am-4pm ET.

Root cause

Error in labeling

Status

Terminated

Product code

ECI

Quantity affected

22 packs

Distribution

Worldwide Distribution-- USA (nationwide) including the states of FL, KY, MN, NJ, SD, and VA., and the country of Australia.

Date initiated

2011-08-18

Date posted

2011-10-05

Date terminated

2012-02-06

Location

Jacksonville, FL